职位描述
该职位还未进行加V认证,请仔细了解后再进行投递!
How You Will Achieve It
- Process TMF documents received per good documentation practices, TMF readiness critieria and other reference documents
- Demonstrate understanding of document types, properties and indexing requirements
- Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
- Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
- Communicate document inquiries with responsible users as needed
- Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
- Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed
- Contribute to process improvement initiatives and projects that may arise
- Can be identified as Subject Matter Expert for TMF process, systems and related tools, where applicable
- Bachelor's Degree
- Demonstrated experience or knowledge of ICH/GCP (International Council for Harmonization/ Good Clinical Practice) documentation requirements
- Hands-on experience with electronic documentation management systems and/or web based data management systems
- Awareness of clinical development process including knowledge and understanding of the principles of Good Clinical Practice
- Understanding of regulatory requirements and relevant data standards
- Consistent, detail-oriented, and dedicated to excellence
- Strong oral and written English communications skills
- Proficiency in the use of Microsoft Office Suite of tools
- Experience in management of medical and clinical study records and documentation
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical#LI-PFE
工作地点
地址:武汉洪山区光谷生物城


职位发布者
辉瑞HR..HR
辉瑞制药有限公司

-
制药·生物工程
-
1000人以上
-
外商独资·外企办事处
-
碑林区和平路116号金鼎大厦303
相似职位
-
案场礼宾司(西安) 5000-6000元长安区 应届毕业生 不限重庆华宇第一太平戴维斯物业服务集团有限公司
-
业务代表(盱眙) 面议长安区 应届毕业生 不限江苏太古可口可乐饮料有限公司
-
渠道经理(政府关系)——西安 10000-20000元长安区 应届毕业生 本科北京小桔科技有限公司
-
300/天提供吃住岗位待遇好有无经验均可(可接受寒假工) 7000-10000元长安区 应届毕业生 不限陕西云聘人力资源有限公司
-
电机工程师 15000-24000元长安区 应届毕业生 本科比亚迪股份有限公司
-
计算机安全保密管理员(西安) 8000-15000元长安区 应届毕业生 本科北京航天科工世纪卫星科技有限公司